BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 24341768 · Received February 15, 2026

    Report

    Report Number
    1213643-2026-00140
    Event Type
    Injury
    Date Received
    February 15, 2026
    Date of Event
    January 1, 2019
    Report Date
    January 29, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    UDI-DI
    00801741095337
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT ONE OF THE STUDY PATIENT EXPERIENCED POST OPERATIVE HERNIA RECURRENCE. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE PHASIX ST MESH. HERNIA RECURRENCE IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2019) IS CONSIDERED TO BE A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "VALIDATION OF THE ACS-NSQIP SURGICAL RISK CALCULATOR FOR PATIENTS WITH PARAOESOPHAGEAL HERNIAS UNDERGOING ROBOTIC REPAIR" THE OBJECTIVE OF THIS STUDY WAS TO MEASURE THE ACCURACY OF THIS CALCULATOR ON PARAOESOPHAGEAL HERNIA (PEH) REPAIR. PROCEDURES PERFORMED BETWEEN 2019 AND 2023 WERE RETROSPECTIVELY COLLECTED REGARDING DEMOGRAPHICS, OPERATIVE VARIABLES, AND OUTCOMES WITH A 30-DAY FOLLOW-UP. THIRTEEN OUTCOMES MEASURED BY NSQIP-ACS CALCULATOR WERE MEASURED. OBSERVED AND PREDICTED RATES WERE COMPARED BY RECEIVER OPERATING CURVES (ROC) AND LENGTH OF STAY WAS COMPARED BY WILCOXON SIGNED RANK TEST. A TOTAL OF 203 PARAOESOPHAGEAL HERNIA REPAIRS ON PATIENTS WITH A MEDIAN AGE OF 68 (IQR 61-75) AND 70.9% (N = 144) PREDOMINANTLY FEMALE. THE SIZE OF THE PARAOESOPHAGEAL HERNIA (PEH) WAS LARGE OR GIANT IN 59.1% (N = 120) AND MESH WAS PLACED IN 70.4% (N = 143). THE PREDICTED RISK WAS CONSISTENTLY HIGHER THAN OBSERVED EVENTS ON ALL BUT DISCHARGE DESTINATIONS. EIGHT OUTCOMES HAD NO EVENT TO MEASURE; HOWEVER, THE CALCULATOR ACCURATELY PREDICTED A RISK OF LESS THAN OR EQUAL TO 1% ON ALL OF THESE. THE AREA UNDER THE CURVE (AUC) WAS FAIR (0.6¿0.79) ON DISCHARGE TO NURSING OR REHABILITATION FACILITIES AND FAILED IN THE REST OF THE MEASURABLE OUTCOMES. ALL PROCEDURES WERE PERFORMED WITH THE DA VINCI XI SURGICAL SYSTEM (INTUITIVE SURGICAL INC.) AND INCLUDED HERNIA SAC DISSECTION AND REDUCTION, ESOPHAGEAL MOBILIZATION, AND CRURAL CLOSURE WITH SELECTIVE REINFORCEMENT WITH BIOSYNTHETIC RESORBABLE MESH (PHASIX ST (7 X 10 CM) - "U" SHAPED; CR BARD INC., MURRAY HILL, NJ) BASED ON SURGICAL PREFERENCE. POSTOPERATIVE RESULTS WERE 96.6% OF PATIENTS (N = 195) EXPERIENCED NO COMPLICATIONS WITHIN 30 DAYS. ONLY ONE MAJOR COMPLICATION (0.5%) OCCURRED: AN ACUTE GASTRIC VOLVULUS REQUIRING RETURN TO THE OPERATING ROOM, WHICH WAS ALSO THE ONE RECURRENCE OF HERNIA RECORDED WITHIN 30 DAYS. READMISSION OCCURRED IN 2.5% (N = 5) OF PATIENTS. THE CURRENT STUDY CONTRIBUTES TO THE GROWING BODY OF RESEARCH SUPPORTING THE ROBOTIC SURGICAL APPROACH IN PARAOESOPHAGEAL HERNIA REPAIR, DEMONSTRATING EXCELLENT SURGICAL OUTCOMES. THE ACS-NSQIP CALCULATOR COULD BENEFIT FROM ADJUSTMENTS THAT ACCOUNT FOR THE NUANCES OF SURGICAL APPROACH. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402745 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741095337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention